None listed
Conditions
Brief summary
We invited interested people to participate in a research study about ketogenic diets. The study “The Effects of Two Different Supplemental Oils on Keto-Adaptation and Symptoms of Carbohydrate Withdrawal” sought to help us better understand the effects of different food oils on achieving nutritional ketosis, and on symptoms of carbohydrate withdrawal (know as ‘Keto-Flu’). Non-obese, non-diabetic people aged between 30 and 50 years of age who had not previously followed a ketogenic diet and who were not current or former clients of either the lead researcher Cliff Harvey or Secondary Supervisor Mikki Williden were recruited. Participants followed a ketogenic diet prepared by Cliff Harvey for 20 days and recorded ketone levels (by way of a daily blood-prick test), along with a daily questionnaire and diary entry to evaluate a range of physical and psychological indicators of health. This study was completely voluntary and participants could withdraw at any time.
Interventions
Randomised controlled, double-blinded intervention. Comparing the application of supplemental Medium chain triglycerides in the context of a very low carbohydrate, ketogenic diet (VLCKD). A commerical MCT oil (Amtrade Industries NZ) consisting of <1% C:6 (caproic), 50-65% C:8 (caprylic), 34-45% C:10 (capric) acids with less than 3% in other (C:12-C:14) fats, was provided to participants at a dose of 30g, three times per day (total 90g per day, of which approximately 45-58.5g was caprylic acid (C
Randomised controlled, double-blinded intervention. Comparing the application of supplemental Medium chain triglycerides in the context of a very low carbohydrate, ketogenic diet (VLCKD). A commerical MCT oil (Amtrade Industries NZ) consisting of <1% C:6 (caproic), 50-65% C:8 (caprylic), 34-45% C:10 (capric) acids with less than 3% in other (C:12-C:14) fats, was provided to participants at a dose of 30g, three times per day (total 90g per day, of which approximately 45-58.5g was caprylic acid (C:8) and 30.6-40.5g was capric acid (C:10), for a duration of twenty days. Supplemental oils self-administered orally in the homes of participants. MCT provided to participants, along with dietary intervention plan by a registered clinical nutritionist of 18 years experience. Supplemental oils (MCT or control) delivered in-person at a pre-study information session, along with the diet plan. Participants prescribed a ketogenic diet with a 4:1 lipid to non-lipid ratio with food self-administered based on the diet plan for the duration of the study (20 days). Males allocated a diet containing 2200 calories and females 1800 calories each equating to 80% calories from fat (including supplemental oils), 13-17% from protein and 3-6% from carbohydrate. Minor differences in carbohydrate and protein were due to the use of a protein intake of 1.4 g.kg-1 of (population-mean for male and female respectively) bm.day-1, in accordance with International Society of Sports Nutrition (ISSN) guidelines for optimal protein intake. Participants were provided with a two-hour pre-study information session describing the diet and with a chance to ask questions and to receive the diet plan and supplemental oils. The pre-study information session was conducted by Cliff Harvey, a registered clinical nutritionist. This was further supported by 2 x 1-hour online workshops prior to study commencement for further clarification and for those unable to attend one of the other workshops (also run by CH - a registered clinical nutritionist). Throughout the study, participants were supported by the lead researcher, a registered clinical nutritionist, as needed. Adherence to the diet and supplementation was self-accountable, self-reported and not monitored by food diary or other means.
Sponsors
AUT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
30-50 years old
Exclusion criteria
Less than 30 years of age or greater than 50 years of age. Obese, as defined by a BMI greater than 30. Those who have previously followed, or are currently following, a ketogenic diet. Diagnosed diabetic (type 1 or 2) As the primary purpose of the study is to better understand induction times for ketosis, and symptoms of ketosis induction, those following a ketogenic diet currently (and therefore in ketosis) would be excluded. Those who have previously followed a ketogenic diet may induce ketosis more rapidly and thereby confound results. There is a dearth of research in this area, but the primary researcher’s clinical observations indicate that it is likely that previous ketogenic diet use may encourage a faster induction into ketosis.
Outcome results
None listed